FDA reverses course and will review Moderna’s mRNA flu shot, company says

By Deidre McPhillips, CNN

(CNN) — The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday.

About two weeks ago, the FDA sent Moderna a letter in which it refused to accept the application to review its first mRNA seasonal flu vaccine — a rare move by the federal agency that raised concern about another setback for the technology that’s been a target of some Trump administration health officials.

The FDA told Moderna that its application didn’t contain an “adequate and well-controlled” trial because the control arm didn’t reflect the “best-available standard of care in the United States at the time of the study,” according to the letter, that Moderna posted online. It didn’t identify any safety or efficacy concerns, the company said.

But Moderna has since met with the FDA and “proposed a revised regulatory approach” with different pathways by age, according to a news release from the company.

Moderna is now “seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” the news release said.

“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Andrew Nixon, a spokesperson for the US Department of Health and Human Services, said in a statement. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”

If the FDA approves the vaccine, it could be available for people ages 50 and older for the upcoming 2026-2027 flu season.

Last week, Moderna said that the initial refusal from the FDA was inconsistent with previous feedback from the agency.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”

CNN’s Meg Tirrell and Adam Cancryn contributed to this report.

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